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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04924309
Other study ID # 20210328
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 5, 2021
Est. completion date April 20, 2022

Study information

Verified date September 2021
Source Women's Hospital School Of Medicine Zhejiang University
Contact Yimin Zhu, Dr.
Phone 057189992071
Email zhuyim@zju.edu.cn
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Donor sperm provides a viable option for patients with significant male factor infertility. However, since the source of sperm is not from the male partner, the psychological burden of these couples is more pronounced and complex than other patients.The purpose of this study is to investigate the stress faced by participants undergoing assisted reproduction with donor sperm and to further investigate its impact on pregnancy outcomes.


Description:

The number of infertility patients has increased significantly in recent years, and infertility caused by the male partner accounts for about 30%-50% of infertility factors. Donor sperm provides a viable option for patients with significant male factor infertility. However, since the source of sperm is not from the male partner, the psychological burden of these couples is more pronounced and complex than other patients. Many factors such as social, marital, and family problems may contribute to their depressed emotional state. And the impact of these negative emotions on pregnancy outcomes cannot be ignored. In this study, investigators intend to investigate the stress faced by participants undergoing assisted reproduction with donor sperm to provide a reliable basis for future psychological interventions and health education for this group of patients and improve the quality of life of infertility patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date April 20, 2022
Est. primary completion date March 20, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Female partners' >18< 40 years - Male partners' >18< 40 years - Patients undergoing assisted reproductive technology with donor sperm or husband's semen due to male factor Exclusion Criteria: - Female partners with polycystic ovary - Female partners with insufficiency or premature ovarian failure - Female partners with endometriosis - Female partners with abnormal profile of thyroid hormones - Chromosomal abnormalities of either spouse - Mental disorder of either spouse

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exposure: donor sperm
One group use donor sperm through the process of assisted reproduction and the other uses husband's semen.

Locations

Country Name City State
China Women's Hospital, School of Medicine, Zhejiang University Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Women's Hospital School Of Medicine Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Implantation rate Implantation rate is defined as number of sacs per embryo transferred. 8 months
Primary clinical pregnancy rate presence of at least one gestational sac on ultrasound of 6 weeks 8 months
Secondary fertilization rate No. of fertilized oocyte divided by No. of inseminated cumulus-oocyte complexes (COCs) 8 months
Secondary cleavage rate No. of cleaved embryo divided by No. of fertilized oocyte 8 months
Secondary Total gonadotropin use Total gonadotropin use of each participant 8 months
Secondary Ovarian hyperstimulation syndrome (OHSS) rates OHSS rates in both study groups 8 months
Secondary Number of oocytes retrieved 8 months
Secondary Metaphase II (MII) oocytes the number of mature oocytes 8 months
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